Objective: To evaluate whether the recommendation to offer a pacifier once lactation is well established reduces the prevalence or duration of breastfeeding.
Study design: A multicenter, randomized, non-inferiority, controlled trial comprising 1021 mothers highly motivated to breastfeed whose newborns regained birth weight by 15 days. They were assigned to offer versus not to offer pacifiers. Primary outcome was prevalence of exclusive breastfeeding at 3 months. Main secondary outcomes were the prevalence of exclusive and any breastfeeding at different ages and duration of any breastfeeding.
Results: At 3 months, 85.8% infants in the offer pacifier group and 86.2% in the not offer pacifier group were exclusively breastfeeding (risk difference, 0.4%; 95% CI, -4.9%-4.1%), satisfying the pre-specified non-inferiority requirement of -7%. Furthermore, the recommendation to offer a pacifier did not produce a significant decrease in the frequency of exclusive and any breastfeeding at different ages or in the duration of lactation.
Conclusions: The recommendation to offer a pacifier at 15 days does not modify the prevalence and duration of breastfeeding. Because pacifier use is associated with reduced incidence of sudden infant death syndrome, the recommendation to offer a pacifier appears safe and appropriate in similar populations.